AmpleLogic cloud-based Pharma QMS solution is tailored for Pharmaceutical, Biotech, Contract Research Organization (CRO), Medical Devices, Contract Development and Manufacturing Organization (CDMO), Active Pharmaceutical Ingredient (API) Manufacturers, Food & Beverages, Beauty & Cosmetics, Medical Devices, Gene Therapy other drug manufacturing businesses. It assists QA, QC, Manufacturing and R&D tackle deviations with real-time insights, excellent integration, comprehensive change control and CAPA. Streamline supplier management, manage costs, market complaints and product recalls with continuous improvement and be audit ready always!
Efficiently manage quality and ensure audit readiness
Clean and organized dashboard for quick and better module navigation
Enables seamless quality management from any device, anytime, anywhere
Advanced API integration for streamlined data collection and analysis
Ensuring adherence to regulations and guidelines like 21 CFR PART 11, EU ANNEX 11, cGMP, GLP, GCP, and others, while maintaining data integrity and accuracy, is crucial for achieving compliance standards, quality assurance, and patient safety.
The pharmaceutical industry faces challenges such as data manipulation, system errors, or glitches while retrieving data. These issues can impact both internal and external audits, ultimately affecting overall quality management and compliance.
Managing the quality and consistency of raw materials, ensuring supplier compliance, and addressing logistical disruptions. Any supply chain break can compromise product quality, delay manufacturing, and disrupt distribution, impacting compliance and patient safety.
Unexpected product quality failures, adverse drug reactions, or manufacturing defects may lead to product recalls. Recalls can damage brand reputation, incur financial losses, and result in regulatory penalties.
Pharma businesses often find trouble in getting their hands on the best integrated software for quality management. This slows down processes or leads to inaccurate fetched data, thus affecting audits and hinders decision making.
There is a lack of communication between pharma R&D, manufacturing, quality assurance, regulatory affairs, and supply chain teams that affects quality management and causes troubles during audits.
Choosing the right Pharma Quality Management Software is crucial for the regulated sector. AmpleLogic Pharma QMS solution complies with 21 CFR part 11, EU ANNEX 11, cGMP, ISO 9001:2005, ISO 14001, ISO 18001/45001, ISO 31000, GHGRP. It helps you identify and tackle deviations using OOS & OOT identification, CAPA and Change Control. Measure Vendor qualification, manage audits and market complaints, report lab incidents and much more! Navigate complex regulations with AmpleLogic GAMP Pharma QMS solution.
Automatic alerts and prompts ensure quick authorization and closure
Ensures a secure and compliant environment for critical data assets
Configured to analyse unique business workflow
AmpleLogic Pharma eQMS ensures compliance with global regulations
Discover the robust features that make, AmpleLogic QMS a pinnacle in quality management
Manage quality efficiently with proper analysis and addressal of issues and quality concerns
Gain insights into the root cause of variances by tracking and analyzing deviations
Mitigate risks effectively under the quality risk management system, ensuring proactive identification and resolution of potential issues
Streamlines auditing process by automating audit scheduling, tracking findings, and ensuring compliance
Amplify Quality Management with CAPA Tracking, Change Control, Market Complaints, Deviation Management, Audit Management, Vendor Qualification, OOS, OOT and Lab Incident Reporting
Enhanced CAPA (Corrective and Preventive Action) capabilities provides methodical approach to inquiry, process mapping, and problem management. Also analyze the efficiency of CAPA
Delivers measurable cost savings and productivity improvements, offering strong return on investments
System’s layout is designed for easy and logical navigation with clear labels and consistent structure across all modules. Users can effortlessly switch between tasks without unnecessary clicks or confusion
Access actionable insights instantly with real-time data analytics for informed decision-making and proactive quality management
Enhances communication with customers and regulatory authorities
Identify trends, monitor performance, and drive actionable insights through reports across all aspect of your quality management process
Trend analysis for monitoring manufacturing process changes and take risk-based decisions
Ensures continuous improvement of processes with detailed quality management
Streamline quality management with a single sign-in, while role-based access ensures users see only relevant information, boosting efficiency and productivity
Offers flexibility and secure access from anywhere, eliminating the need for extensive IT infrastructure and ensuring your quality control is always available
Designed to scale with your business, adapting to increased production, regulatory changes, and new products while ensuring consistent quality and compliance
Web-based application ensures 24x7 end-user access to a secure centralized database
Timeline visibility to handle major and minor issues saving resources and time
Activity Closure timelines with and without extensions
Get detailed insight on pending tasks with stage wise record and elaborate viewing history
Monitor unit/department productivity and efficiency through KPI-driven evaluation metrics and traceability trends
Easily integrates with ERP, SAP, MES, DMS, LMS, RIMS, LIMS, ERP, Legacy Systems and other third-party systems
All pharma quality management procedures are initiated, approved, assessed, and verified online with electronic signatures and activity stamps
Detailed tracking of workflows, processes, modules, and admin-level operations
As a web-based solution, AmpleLogic Pharma QMS eliminates geographical hindrances
Web-based access ensures openness and detailed traceability throughout Integrated Quality Systems
Adaptable workflow, compliant with 21 CFR Part 11 and tailored to customer’s procedure
Satisfies electronic record standards of TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA, and MoH.
Compliant with US FDA 21 CFR Part 11, EU Annexure 11, GAMP 5 standard, GMP, Alcoa+ Principles, ISO 9001:2005, ISO 14001, ISO 18001/45001, ISO 31000, GHGRP, etc
Maintaining cleanliness and hygiene in pharmaceutical manufacturing is crucial for ensuring product safety and quality, with patient well-being as the top priority. Cleaning validation plays
Root Cause Analysis (RCA) is a method that is used to address a problem or non-conformance in the quality process to get to the “root
Root Cause Analysis (RCA) is a method that is used to address a problem or non-conformance in the quality process to get to the “root
In conversation with Avanish Kumawat, Snr. Manager QA and Ramesh Reddy, Manager QAAnnora Pharma, a leading pharmaceutical company based in Hyderabad, India, specializes in manufacturing
Sales targeting is the challenging task in pharma companies as they deal with 5000 – 12000 SKU’s with 1000+ field staff. Currently, the sales targeting process is done through
Sun Pharma is India’s fast growing manufacturing pharmaceutical Industry, promoting branded generic products in Indian & International Markets. Challenge with manual excel solution Manually performing
Industry-Specific Software for Enhanced Quality and Compliance
Root Cause Analysis (RCA) is a method that is used to address a problem or non-conformance in the quality process to get to the “root
Root Cause Analysis (RCA) is a method that is used to address a problem or non-conformance in the quality process to get to the “root
Integration of AI & ML in Quality Management Systems There is no doubt that we have entered the new industrial revolution, commonly referred to
A Quality Management System (QMS) is a formalized framework documenting processes, procedures, and responsibilities to achieve quality objectives and ensure compliance with regulatory standards.
AmpleLogic’s Quality Management Software is highly customizable, allowing companies to implement personalized changes that align with their unique business processes and address specific concerns.
AmpleLogic’s eQMS is a top choice for quality management in lifesciences, food & beverages (F&B), beauty & cosmetics, medical devices, and the gene therapy industry.
AmpleLogic’s ISO 9001 QMS software adheres to crucial international regulations, including US FDA 21 CFR Part 11, EU Annexure 11, GAMP 5 standard, GMP, TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA, and MoH, along with Alcoa+ Principles.
We provide customization benefits on all our COTS products including the QMS software. The application has been built keeping in mind the regulatory compliances of various industries around the globe. It provides seamless data and API integration, enhancing transparency and authorization; thereby improving audit quality.
Our solutions are available and accessible globally, ensuring businesses worldwide can benefit from our expertise in quality management.
QMS software is designed to streamline quality management processes and ensure regulatory compliance. Key features include document management, non-conformance tracking, CAPA (Corrective and Preventive Actions), audit management, risk management, training management, change control, supplier quality management, complaint handling, and quality metrics reporting. These features help organizations maintain product quality and operational efficiency.
Yes, AmpleLogic offers a cloud-based Quality Management System (QMS) software tailored for pharmaceutical manufacturing companies. It simplifies managing quality processes, helps meet GMP and FDA regulations, and improves product quality. Since it’s cloud-based, you can access it from anywhere, track real-time data, and securely store important information. It’s a practical solution that makes quality management easier and more efficient for your team.
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Cleaning Validation Software
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